FDA.reportPublic FDA data

Rexall Sensitive Freshmint

Manufacturer
Old East Main CO. | Ashtel Studios Inc.
Effective date
2024-10-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:25:46

Label at a glance#

ProductRexall Sensitive Freshmint
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure9 sections

Indications and uses

Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact • aids in the prevention of dental cavities

Dosage and administration

• Adults and children 12 years & older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush • brush teeth thoroughly for at least two minutes, preferably after each meal or at least twice a day (morning and evening) as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth. • minimize swallowing. Spit out after brushing. • Children under 12 years of age: ...

Storage and handling

Store at room temperature 68-77°F (20-25°C)

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Potassium Nitrate (5%)
Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Antihypersensitivity
Anticavity

Uses

INDICATIONS & USAGE SECTION

Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact • aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

Stop use and ask a dentist if • the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist • pain/sensitivity still persists after 4 weeks of use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• Keep out of reach of children under 12 years of age. If more than amount used for brushing is accidentally swallowed, seek medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

• Adults and children 12 years & older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush • brush teeth thoroughly for at least two minutes, preferably after each meal or at least twice a day (morning and evening) as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth. • minimize swallowing. Spit out after brushing. • Children under 12 years of age: Consult a dentist or doctor.

Other information

STORAGE AND HANDLING SECTION

Store at room temperature 68-77°F (20-25°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Sorbitol, Hydrated Silica, Treated water, PEG-32, Sodium Lauryl Sulfate, Flavor, Glycerin, Cellulose Gum, Tetrasodium Pyrophosphate, Titanium Dioxide, Benzyl Alcohol, Sodium Benzoate, Trisodium Phosphate, Sodium Saccharin, D&C Yellow #10, FD&C Blue #1

SPL UNCLASSIFIED SECTION

MAXIMUM STRENGTH

TOOTHPASTE WITH FLUORIDE

• For sensitive teeth and cavity protection

Brushing twice a day builds a protective coating against painful sensitivity.

• Contains potassium nitrate, clinically proven to reduce painful sensitivity
• Fluoride for cavity protection
• Great taste keeps mouth feeling fresh & clean

Since 1903 Rexall™ is a trademark of Rexall Sundown, Inc.

100% satisfaction Guaranteed!
(888) 309-9030

DISTRIBUTED BY OLD EAST MAIN CO.
100 MISSION RIDGE,
GOODLETTSVILLE, TN 37072

MADE IN INDIA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Old East-819Old East-819

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN2
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD2
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY2
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY2
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY2
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY2
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55910-819-012024-10-15C16284748780-11030e365-294e-111a-e063-dadaa90a10e2Rexall ™ SENSITIVE TOOTHPASTE WITH FLUORIDE - FRESH MINT
55910-819-012024-01-30C16284748780-11030e365-294e-111a-e063-dadaa90a10e2Rexall ™ SENSITIVE TOOTHPASTE WITH FLUORIDE - FRESH MINT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-819-01Rexall Sensitive Freshmint1 in 1 BOXPASTE, DENTIFRICE12
55910-819-01Rexall Sensitive Freshmint113 g in 1 TUBEPASTE, DENTIFRICE1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-819REXALL SENSITIVE FRESHMINT (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [OLD EAST MAIN CO.]2Current NDC, Legacy NDC, 2 package rows20241017_7e715bb9-666e-4de4-ba70-1c84f5243443.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55910-81955910-819-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM NITRATERU45X2JN0ZACTIB
SODIUM FLUORIDE8ZYQ1474W7ACTIM
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL 16001212Z7S33AIACT
SODIUM LAURYL SULFATE368GB5141JIACT
GLYCERINPDC6A3C0OXIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
BENZYL ALCOHOLLKG8494WBHIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSSX01TZO3QZIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rexall Sensitive FreshmintPOTASSIUM NITRATE, SODIUM FLUORIDEOld East Main CO.7e715bb9-666e-4de4-ba70-1c84f52434432024-10-14WarningsExact identifier
ndc (package): 55910-819-01
ndc (product): 55910-819
ndc11 (package): 55910081901
spl id: 390f2bad-b45f-41c8-9fd8-16796a40a14b
spl set id: 7e715bb9-666e-4de4-ba70-1c84f5243443

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.